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  6. DDT COA #000127: Functional Vision Questionnaire (FVQ) ObsRO
  1. Clinical Outcome Assessment (COA) Qualification Program

DDT COA #000127: Functional Vision Questionnaire (FVQ) ObsRO

Clinical Outcome Assessments (COA) Qualification Submissions
Office of Specialty Medicine (OSM)
Division of Ophthalmology (DO)

DDT COA Number
DDT COA #000127

Instrument Name
Functional Vision Questionnaire (FVQ) ObsRO

Disease/Condition
Retinitis Pigmentosa

Concept of Interest
Visual function and functional vision

Context of Use
Pediatric (3-11 years) patients with a clinical and genetic confirmed diagnosis of RP

COA Type
ObsRO

Qualification Stage
Letter of Intent- Accepted

Requestor(s)
Novartis Pharmaceuticals Corporation

Contact(s)
Orin Tempkin

Date Accepted into CDER’s COA Qualification Program
June 5, 2020

Submission and Regulatory Correspondence History

Qualification Submission Date FDA Submission Decision & Recommendations Date
Letter of Intent 3/18/20 FDA Response (Accepted) 6/5/20
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